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Health Technical Memorandum

01-01: Management and

decontamination of surgical
instruments (medical devices)
used in acute care
Part A: Management and provision

July 2016
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Health Technical Memorandum

01-01: Management and
decontamination of surgical
instruments (medical devices)
used in acute care
Part A: Management and provision

ii
© Crown copyright 2016

You may re-use this information (not including logos) free of charge in any format or me-
dium, under the terms of the Open Government Licence. To view this licence, visit www.
nationalarchives. gov.uk/doc/open-government-licence/ or write to the Information Policy
Team, The National Archives, Kew, London TW9 4DU, or email: [email protected].
gov.uk.
This document is available from our website at www.gov.uk/government/collections/
health-building-notes-core-elements

iii
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Preface

Introduction HTM 01-01 forms a suite of evidence-based

policy and guidance documents on the
This HTM supersedes the Choice Framework management and decontamination of reusable
for local Policy and Procedures (CFPP) series, medical devices.
which was a pilot initiative by the Department of
Health.
Purpose
The CFPP series of documents are reverting to The purpose of this HTM is to help health
the Health Technical Memorandum title format. organisations to develop policies regarding the
This will realign them with HTM 00 – ‘Policies management, use and decontamination of
and principles of healthcare engineering’ and reusable medical devices at controlled costs
‘HTM 01-05: Decontamination in primary care using risk control, which will enable them to
dental practices’ and the naming convention comply with Regulations 12(2)(h) and 15 of the
used for other healthcare estates and facilities Health and Social Care Act 2008 (Regulated
related technical guidance documents within Activities) Regulations 2014 .
England. It will also help to address the
recommendation to align decontamination This HTM is designed to reflect the need to
guidance across the four nations. continuously improve outcomes in terms of:
In 01-01 and 01-06 DH will be retaining the • patient safety;
Essential Quality Requirements and Best
Practice format, this maintains their alignment • clinical effectiveness; and
with HTM 01-05 and the requirement of ‘The • patient experience.
Health and Social Care Act 2008: Code of
Practice on the prevention and control of
infections and related guidance’ which requires Essential Quality Requirements and
that “decontamination policy should Best Practice
demonstrate that it complies with guidance
establishing essential quality requirements and The Health Act Code of Practice recommends
a plan is in place for progression to best that healthcare organisations comply with
practice”. We are aware that policy within the guidance establishing Essential Quality
devolved nations differs on this particular issue Requirements and demonstrate that a plan is in
but the aim is that the technical content should place for progression to Best Practice.
be consistent and able to be adopted by the
Essential Quality Requirements (EQR), for the
devolved nations so that the requirements of
purposes of this best practice guidance, is a
the ACDP-TSE Subgroup’s amended guidance
term that encompasses all existing statutory
can be met.
and regulatory requirements. EQRs incorporate
requirements of the current Medical Devices

iv
Directive and Approved Codes of Practice as The HTM 01 suite is listed below.
well as relevant applicable Standards. They will
help to demonstrate that an acute provider • HTM 01-01: Management and
operates safely with respect to its decontamination of surgical instruments
decontamination services. (medical devices) used in acute care
• HTM 01-04: Decontamination of linen for
A healthcare provider’s policy should define health and social care
how it achieves risk control and what plan is in
place to work towards Best Practice. • HTM 01-05: Decontamination in primary
care dental practices [check title]
Best Practice is additional to EQR. Best
Practice as defined in this guidance covers • HTM 01-06: Decontamination of flexible
non-mandatory policies and procedures that endoscopes.
aim to further minimise risks to patients; deliver
better patient outcomes; promote and Note
encourage innovation and choice; and achieve
cost efficiencies. This guidance remains a work in progress
which will be updated as additional evidence
Best Practice should be considered when becomes available; each iteration of the
developing local policies and procedures based guidance is designed to help to
on the risk of surgical procedures and available incrementally reduce the risk of cross-
evidence. Best Practice encompasses infection.
guidance on the whole of the decontamination
cycle, including, for example, improved
instrument management, where there is
evidence that these procedures will contribute
to improved clinical outcomes.

v
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Foreword

This guidance has been developed to support health organisations in delivering the required
standard of decontamination of surgical instruments and builds on existing good practice to
ensure that high standards of infection prevention and control are developed and maintained.

The guidance in this Health Technical Memorandum should inform your local continuous
improvement programme on decontamination performance. The major change in this latest
revision is taking account of recent changes to the Advisory Committee on Dangerous Pathogens
Transmissible Spongiform Encephalopathy (ACDP-TSE) Subgroup’s general principles of
decontamination (see ACDP-TSE’s Annex C). This establishes a move towards in situ testing for
residual proteins on instruments. Residual protein is important because of the continuing risks of
transmission of prions (the causative agent of transmissible spongiform encephalopathies such as
variant Creutzfeldt-Jakob disease (vCJD)).

This guidance provides information on how sterile services departments (SSDs) can mitigate the
patient safety risk from residual protein with a move towards first achieving this ≤5 μg level and
subsequently producing further reductions in protein contamination levels through the optimisation
of decontamination processes. The ambition is that all healthcare providers engaged in the
management and decontamination of surgical instruments used in acute care will be expected to
have implemented this guidance by 1 July 2018. However, providers whose instruments are likely
to come into contact with higher risk tissues, for example neurological tissue, are expected to give
this guidance higher priority and move to in situ protein detection methodologies by 1 July 2017.

Professor Dame Sally Davies

Chief Medical Officer

vi
Executive summary

Health Technical Memorandum (HTM) 01-01 Part D covers standards and guidance on
offers best practice guidance on the whole washer-disinfectors.
decontamination cycle including the
management and decontamination of surgical Part E covers low temperature (non-steam)
instruments used in acute care. sterilization processes (such as the use of
vapourised hydrogen peroxide gas plasmas
Part A covers the policy, management and ethylene oxide exposure).
approach and choices available in the
formulation of a locally developed, risk- HTM 01-01 Part A 2016 supersedes all previous
controlled operational environment. versions of CFPP 01-01 Part A.
The technical concepts are based on European
(EN), International (ISO) and British (BS)
Standards used alongside policy and broad
Why has the guidance been
guidance. In addition to the prevention of updated?
transmission of conventional pathogens, HTM 01-01 has been updated to take account
precautionary policies in respect of human of recent changes to the ACDP-TSE
prion diseases including variant Creutzfeldt- Subgroup’s general principles of
Jakob disease (vCJD) are clearly stated. Advice decontamination (Annex C). In relation to the
is also given on surgical instrument decontamination of surgical instruments, this
management related to surgical care principally relates to paragraphs C21 and C22:
efficiencies and contingency against
perioperative non-availability of instruments. Protein detection
C21. Work commissioned by the Department of Health
Part B covers common elements that apply to indicates the upper limit of acceptable protein
all methods of surgical instrument reprocessing contamination after processing is 5µg BSA equivalent per
instrument side. A lower level is necessary for
such as:
neurosurgical instruments.
• test equipment and materials
C22. It is necessary to use protein detection methods to
check for the efficient removal of protein from surgical
• design and pre-purchase considerations
instruments after processing. Protein levels are used as an
indication of the amount of prion protein contamination.
• validation and verification. Ninhydrin swab kits are commonly used for this purpose,
but recent evidence shows that ninhydrin is insensitive.
Part C covers standards and guidance on Furthermore, proteins are poorly desorbed from
steam sterilization. instruments by swabbing. Other commonly used methods
have also been shown to be insensitive.

vii
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

The ACDP-TSE Subgroup’s guidance What SSDs can do to ensure

requires that there should be ≤5 µg of implementation of the ACDP-TSE
protein in situ on the side of any instrument Subgroup’s recommendations
tested. The rationale for each of these
elements is as follows: Because of the risks of prion transmission,
there is a need to optimise the whole of the
• The figure of 5 µg of protein has been decontamination pathway of surgical
shown to be achievable by effective instruments.
cleaning processes. There is currently no
definitive evidence base to link this with Reducing the time from close of procedure
the absence of prion transmission risk, to reprocessing
which is why lower levels for instruments
making contact with high risk tissues (see Prions are easier to remove if they have not
ACDP-TSE’s Annex J) is necessary. dried on the surface of an instrument. To
enable efficient prion removal, theatre and SSD
• The measurement is per side of staff should ensure that instruments are
instrument rather than per unit area of an transported to the SSD immediately after the
instrument. Prion proteins have been close of the procedure, for cleaning and
shown to be infectious by contact (Kirby et reprocessing as soon as practically possible.
al 2012). Infection transmission would be This will make the cleaning process more
related to the total area of an instrument effective, hence reducing the risks to the
that makes contact with patient tissues. patients and staff handling the devices. If
Thus, while not a perfect relationship, the devices cannot be returned in a timely manner,
assessment of protein levels per side of an it is important that the instruments are kept
instrument is likely to be a greater moist using appropriate methods approved and
predictor of risk control than an verified by the SSD.
assessment based on a unit area of an
instrument. Cleaning validation and continuous
monitoring
• Protein levels on an instrument should be
measured directly on the surface rather Traditionally, cleaning validation has been about
than by swabbing or elution (see the removing visible soiling. Now the emphasis is
ACDP-TSE Subgroup’s Annex C on removing highly adherent proteins to very
paragraph C23), as detection of proteins low levels. To be able to have a greater chance
on the surface of an instrument gives a of removing these sticky proteins, there needs
more appropriate indication of cleaning to be as efficient a cleaning process as
efficacy related to prion risk (see Table C2 possible – therefore SSDs need to both
in ACDP-TSE’s Annex C). As technologies optimise the cleaning performance of washer-
become available that are able to detect disinfectors and remain within the validation
residual protein in situ to ≤5 µg per parameters.
instrument side, they should be adopted.
It is important to continuously monitor the
Prion proteins are very hydrophobic and
residual protein on reprocessed instruments.
will, once dry, adhere strongly to surfaces
SSDs should not view the 5 µg limit as a single
and resist removal by swabbing or elution
pass or fail, but rather use it as a way of
for the purpose of protein detection.
working towards and below this value, that is,
as part of trend analysis and a quality
assurance system whose aim is to monitor not
just the cleaning efficacy of washer-disinfectors
but also the instrument journey leading up to
that stage – in other words, ensuring results are
viii
being monitored and actions are being taken ‘Managing medical devices: guidance for
based on these results. SSDs should include: healthcare and social services organisations’
and also ‘Medical devices: conformity
• daily testing using process challenge assessment and the CE mark’).
devices* (along with the standard periodic
tests);
Residual protein detection devices should
• quarterly residual protein testing (see be intended by their manufacturer to be
paragraphs 2.271–2.277 in HTM 01-01 used as an accessory to a surgical
Part D –’Validation and verification’). instrument that has undergone a cycle
See also Appendix B in this document for through a washer-disinfector validated to BS
example sampling rates. EN ISO 15883 Parts 1 and 2 for washing
and disinfecting of surgical invasive devices
Priority for cleaning validation and continuous and be capable of measuring and detecting
monitoring should be given to instruments that residual protein in situ to levels of ≤5 µg per
have contact with high-prion-risk tissues as side of used, washed surgical instruments.
defined by ACDP-TSE (see Table A1 in ACDP- The manufacturer will need to have CE-
TSE’s guidance Annex A1). marked the product under the Medical
Devices Regulations and issued a
* Commercial process challenge devices are declaration of conformity to demonstrate
being developed whose challenge simulates that the device has met all relevant essential
the attachment of prion protein to requirements for the medical device and that
instruments and whose analysis is they have followed an appropriate
quantitative. When these become available conformity assessment route.
and have been validated, SSDs are advised
to consider their use in addition to process Until such time as these are available
challenge devices based on soils in BS EN as medical devices, residual protein
15883-5 Annex N. control relies mainly on controlling the
decontamination process rather than
on protein detection from instruments
Results from the quarterly residual protein test – that is, process control makes more
should be used to analyse trends and act on of a contribution than product control.
that analysis. When high resolution methods of
detecting residual protein in situ are
Methods for detecting residual protein available, then product control should
be used to inform process control.
SSDs should no longer rely on elution or
swabbing to detect residual protein on an
instrument. The method should be validated as
Continuous improvement plans
being able to detect protein equivalent to ≤5 µg
of BSA in situ on the surface of an instrument. SSDs should have in place a plan of continuous
Commercial technologies that can detect the process improvement. This plan should be
5 µg limit in situ are being developed (see carried out as part of a risk management plan
ACDP- TSE’s Annex C). Methods that do not (see BS EN ISO 14971 on medical device risk
have protein as their target, such as ATP management). There should also be a specific
assays, cannot be used as a substitute for record that relates to residual protein trend
residual protein detection. Devices to detect analysis.
residual protein must be CE-marked as an
accessory to a medical device (see the MHRA’s

ix
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Implementation of guidance List of major changes to Part A

The ambition is that all healthcare providers • CFPP 01-01 has reverted to the Health
engaged in the management and Technical Memorandum title format and
decontamination of surgical instruments used in now becomes Health Technical
acute care will be expected to have updated Memorandum 01-01.
their local policies and continuous improvement • New guidance included on how to ensure
plans in line with this guidance by 1 July 2018. implementation of the ACDP-TSE’s
However, providers whose instruments are likely Subgroup’s recommendations.
to come into contact with higher risk tissues, for
example neurological tissue, are expected to • Chapter 5 on prion diseases updated to
give this guidance higher priority and move to reflect the changes to the ACDP-TSE
in situ protein detection methodologies by Subgroup’s guidance (2015).
1 July 2017.
• In the section on “Separation of
instruments used on high risk tissues for
patients born before and after 1 January
1997” in Chapter 6, the management of
instruments for the small number of
patients born after 1 January 1997 who
have already had past high risk tissue
surgery using pre-1997 instruments has
been amended (see paragraphs 6.8–6.10)
in line with both the views of the Society
of British Neurological Surgeons and the
ACDP-TSE Subgroup.

x
Acknowledgements

Andrew Bent Medicines & Healthcare products Regulatory Agency

Anita C. Jones University of Edinburgh
Bill Keevil University of Southampton
Brian Kirk IHEEM Decontamination Technology Platform
Clive Powell Association of British Healthcare Industries
David Perrett Queen Mary University of London
Geoff Sjogren Institute of Decontamination Sciences
Geoffrey L. Ridgway, OBE, MD Clinical Microbiologist
Graham Stanton NHS Wales Shared Services Partnership – Facilities Services
Helen Griffiths Joint Advisory Group on gastrointestinal endoscopy (JAG)
Jackie Duggan Public Health England
James Ironside University of Edinburgh
Jimmy Walker Public Health England
John Singh Health Estates, Northern Ireland
Karen Chell NHS Supply Chain
Katy Sinka Public Health England
Mike Painter Public Health Physician
Mike Simmons Public Health Wales
Miles Allison British Society of Gastroenterology
Peter Hoffman Public Health England
Robert Kingston IHEEM Decontamination Technology Platform
Rod Herve University of Southampton
Sulisti Holmes Health Protection Scotland
Tony Young Southend University Hospital NHS Foundation Trust
Tracy Coates Association for Perioperative PracticeContents

xi
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Abbreviations

ACDP-TSE [Subgroup]: Advisory Committee on FITC: fluorescein isothiocyanate

Dangerous Pathogens Transmissible
Spongiform Encephalopathy [Subgroup] ISO: International Standards Organisation

ACDST: Advisory Committee on MDD: Medical Devices Directive

Decontamination Science and Technology
MDR: Medical Devices Regulations
AE(D): Authorising Engineer (Decontamination)
MHRA: Medicines and Healthcare products
AP(D): Authorised Person (Decontamination) Regulatory Agency

BCH: Birmingham Children’s Hospital NDS: National Decontamination Survey

BS: British Standard NICE: National Institute for Health and Clinical
Excellence
BSE: Bovine Spongiform Encephalopathy
NICE IPG 196 (2006): NICE’s (2006)
CFPP: Choice Framework for local Policy and interventional procedure guidance 196 –
Procedures ‘Patient safety and reduction of risk of
transmission of Creutzfeldt–Jakob disease
CJD: Creutzfeldt-Jakob disease (CJD) via interventional procedures’

CMO: Chief Medical Officer OPA/NAC:

o-phthalaldehyde/N-acetyl-L-cysteine
CP(D): Competent Person (Decontamination)
PO: posterior ophthalmic
CQC: Care Quality Commission
sCJD: sporadic Creutzfeldt-Jakob disease
DH: Department of Health
SSD: sterile services department
DIPC: Director of Infection Prevention and
Control TSEs: transmissible spongiform
encephalopathies
EDIC: episcopic differential interference contrast
UCHL: University College Hospital London
EDIC/EF: episcopic differential interference
contrast/epifluorescence vCJD: variant Creutzfeldt-Jakob disease

EFSCAN: epifluorescent surface scanner

EN: European norm

xii
Contents

Preface�� iv
Foreword�� vi
Executive summary�� vii
Acknowledgements�� xi
Abbreviations�� xii
1 Introduction��1
2 Decontamination policy for reusable surgical instruments��4
3 Guidance for commissioners, regulators and providers�� 10
4 Regulatory framework�� 12
5 Human prion diseases (including variant CJD and other forms of CJD)�� 17
6 Management of surgical instruments��21
Appendix A: Standards relevant to decontamination��31
Appendix B: Example sampling strategy��33
References��44
Bibliography of research articles��46

xiii
1 Introduction

1 Introduction

1.1 This HTM offers best practice guidance on 1.5 HTM 01-01 supports local decision-making
the management and decontamination of in the commissioning, regulation, management,
surgical instruments used in acute care. The use and decontamination of surgical
guidance supports the ‘Health and Social Care instruments used in acute care. The guidance
Act 2008: Code of Practice for the prevention is designed to support continuous
and control of infections and related guidance’ improvements in efficiency and outcomes in
and has been developed to strengthen local terms of safety, clinical effectiveness and
decision making and accountability. This HTM patient experience by:
also supports the vision for the NHS as set out
in the Health and Social Care Act 2012. • providing guidance on compliance with
the ACDP-TSE Subgroup’s guidelines;
1.2 In order to be registered with the Care • guiding care commissioners and
Quality Commission (CQC), providers are regulators in assessing the local policies
required to maintain appropriate levels of and practices of a provider in terms of
cleanliness and hygiene in relation to reusable their approach to the management and
medical devices. The Code of Practice provides decontamination of surgical instruments.
guidance on how providers can meet this Clear definitions of Essential Quality
registration requirement, including key Requirements and Best Practice are
recommendations on the provision of a safe provided in this HTM, to help with this
decontamination service that generates a clean assessment;
and sterile product.
• providing the evidence base and
1.3 The Health and Social Care Act 2012 sets standards for use by providers of care
out the Government’s intention to ensure and those decontaminating surgical
providers are properly regulated, allowing them instruments within the NHS or
to work with clinical commissioners to focus on commercially, to support them in their
improving outcomes, be more responsive to decision-making process;
patients and innovate.
• contributing to the effective management
1.4 The Act also introduces a duty on NHS of surgical instruments through all parts
England (the operating name of the NHS of the use and reprocessing cycle (see
Commissioning Board) and clinical Figure 1). This includes management
commissioning groups to secure continuous practices related to surgical instruments
improvement in the quality of outcomes in the theatre environment;
achieved from health services. These outcomes • providing guidance for service-users and
are to focus on the effectiveness, safety and patient groups on issues that are relevant
patient experience aspects of healthcare. to them. This has been written to take
account of HealthWatch’s future role in

1
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Figure 1 The reusable surgical instrument cycle

ACQUISITION The reusable surgical

1. Purchase instrument cycle
2. Loan

CLEANING
DISINFECTION
(NEW PRION DEACTIVATION
TECHNOLOGY)

TRANSPORT
INSPECTION
(& PROTEIN TESTING)

At all stages:
Location
Facilities
Equipment
USE Management PACKAGING
Policies/Procedures
DISPOSAL
1. Scrap
2. Return to lender

STORAGE
STERILIZATION

TRANSPORT

• working with providers, commissioners • the prevention and control of the risk of
and quality regulators; transmission of infection through surgical
instruments – with specific reference to
• using the experience of previous pilot the theoretical risk of human prion
studies to demonstrate approaches to diseases transmission (transmissible
risk management and to the spongiform encephalopathies, or TSEs);
implementation of the National Institute
for Health and Clinical Excellence’s (NICE) • a comprehensive approach to risk control
interventional procedure guidance 196 – and reduction across instrument
‘Patient safety and reduction of risk of management and decontamination;
transmission of Creutzfeldt–Jakob
disease (CJD) via interventional • assurance over the management of
procedures’ (hereafter referred to as surgical instruments, in terms of
NICE IPG 196 (2006)). availability, quality and suitability;
• the preservation and advance of high-
Note quality engineering through the support
Regulators include the CQC, the Medicines of European Norms (ENs), quality
and Healthcare products Regulatory Agency systems and standards;
(MHRA), and notified bodies. • guidance for optimisation of the
environment, equipment and facilities
1.6 With HTM 01-01, the DH is seeking to used in surgical decontamination.
establish:
1.7 HTM 01-01 refers to NICE IPG 196 (2006)
and guidance derived from the Advisory

2
1 Introduction

Committee on Dangerous Pathogens – the formulation of a locally developed, risk-

Transmissible Spongiform Encephalopathies controlled operational environment.
(ACDP-TSE RM) subgroup throughout. It has
drawn on the findings of the National 1.12 The technical concepts are based on
Decontamination Survey (NDS) (2008–2010) to European (EN), International (ISO) and British
highlight aspects of decontamination (BS) Standards used alongside policy, broad
management practice that need addressing, guidance and research. In addition to the
and the findings from various NDS pilot studies. prevention of transmission of conventional
pathogens, precautionary policies in respect of
1.8 Management recommendations centre on: human prion diseases including variant
Creutzfeldt-Jakob disease (vCJD) are clearly
• ensuring maximum efficiency in protein stated. Advice is also given on surgical
detection and decontamination; instrument management related to surgical care
• improving instrument set integrity efficiencies and contingency against
perioperative non-availability of instruments
• ensuring that a separate pool of new
neuroendoscopes and reusable surgical 1.13 Part B covers common elements that
instruments is available for high risk apply to all methods of surgical instrument
procedures on patients born since 1 reprocessing such as:
January 1997, as it is thought that people
born since 1 January 1997 have had • test equipment and materials
lower exposure to prions via the food • design and pre-purchase considerations
chain or blood transfusion;
• validation and verification.
• ensuring contingency for dropped or
unavailable instruments; 1.14 Part C covers standards and guidance on
steam sterilization.
• ensuring a continuously moist
environment for instruments between use 1.15 Part D covers standards and guidance on
and reprocessing; washer-disinfectors.
• having a system in place for surgical
instrument management and to cover the 1.16 Part E covers low temperature (non-steam)
quality, condition and suitability of sterilization processes (such as the use of
reusable surgical instrument. vapourised hydrogen peroxide gas plasmas
and ethylene oxide exposure).
1.9 Whether decontamination services are
provided by the healthcare provider or from an
external source, the requirements of the
instrument management and decontamination
policy outlined in this guidance should be
followed.

1.10 HTM 01-01 Part A supersedes all previous

versions of CFPP 01-01 Part A.

Structure of HTM 01-01

1.11 HTM 01-01 Part A covers the policy,
management approach and choices available in

3
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

2 Decontamination policy for reusable surgical

instruments

2.1 A safe decontamination service contributes • The theoretical but potentially highly
to successful clinical outcomes and the significant risk of transmission of human
wellbeing of patients and staff. Healthcare prion diseases including, but not limited
providers in England are required by law to to, vCJD.
comply with essential levels of safety and
quality which are assessed by the CQC. These • The availability, quality and suitability of
levels are set in law through registration surgical instruments.
requirements, one of which covers cleanliness • Interruption to, or abandonment of,
and infection control. Guidance on meeting surgery where this is due to instrument
this registration requirement is provided by the quality, the absence of key instruments
‘Health and Social Care Act 2008: Code of from the surgical set or, in very rare
Practice on the prevention and control of instances, where an instrument has been
infections and related guidance’. The Code of dropped perioperatively or otherwise has
Practice recommends that healthcare had its sterility compromised during use.
organisations comply with guidance
establishing Essential Quality Requirements 2.5 In this HTM, a number of options are
and demonstrate that a plan is in place for offered for dealing with risks highlighted by the
progression to Best Practice. NDS (2008–2010). These options are outlined
based on experience gained from pilot studies
2.2 HTM 01-01 draws on DH policy and and guidance, and include information on the
current advice to provide comprehensive observed outcomes. As experience grows,
guidance on the management and individual reports and findings will be
decontamination of surgical instruments used incorporated.
in acute care. This includes clear definitions of
what constitutes Essential Quality
Requirements and Best Practice. The policy context
2.6 HTM 01-01 is best practice guidance. It
2.3 In acute care, precautionary policies in forms an integral part of enabling the delivery of
respect of human prion diseases including the following policy initiatives.
vCJD also apply.
2.7 The Health and Social Care Act 2012 sets
2.4 This guidance therefore seeks to offer out the framework for the government’s vision
advice across a range of risk types. for modernising the NHS. It gives power to
Specifically, these include: clinicians to make commissioning decisions, and
• The risk of infection via surgical gives more choice and control to patients. It also
instruments. establishes Monitor as a strong service regulator
to act in the interests of patients.

4
2 Decontamination policy for reusable surgical instruments

2.8 The NHS Commissioning Board (NHS assessment for surgical instrument
England) will continue to look to providers to management, encompassing the provision of
deliver services that enhance patient safety and instruments that are safe to use and the reliable
the patient experience, and that deliver value for provision of all required instruments.
money. Part of this is a drive towards constant
assurance of correctly selected, clean, sterile 2.13 Local policy should define how a provider
and fully functioning surgical instruments at the achieves risk control and what plan is in place to
point of care delivery. work towards Best Practice.

2.9 The management and decontamination of 2.14 Local policy development that takes
surgical instruments are key components in the account of this HTM could result in amended
delivery of safe interventional care. This guidance theatre practices, such as improvements to the
advocates a full assessment of the volume and audit trail for instruments and the provision of
types of surgical service provided, the instruments sets that do not require the use of
turnaround times required for decontamination, supplementary instruments.
the prion transmission risks associated with the
2.15 Comparison of local policy statements and
tissues encountered in each area of service, and
quality systems with audit results will confirm
the instrument stock required for onsite and
attainment of Essential Quality Requirements
offsite decontamination. To gain a full
and progression towards Best Practice. Such
understanding of the risks involved, including the
assessment could provide a mechanism for
risk of prion disease transmission, see
differentiating between care providers in
paragraph 5.1.
commissioning services.
2.10 In light of this, HTM 01-01 advocates that
2.16 Best Practice is additional to the Essential
commissioners, providers and regulators adopt
Quality Requirements. Best Practice as defined
a risk-control approach to the management of
in this guidance covers non-mandatory policies
single-use instruments and to the management
and procedures that aim to further minimise
and decontamination processes for reusable
risks to patients; deliver better patient outcomes;
surgical instruments, in line with the essential
promote and encourage innovation and choice;
requirements of the Medical Devices Directive
and achieve cost efficiencies.
(MDD) and the ENs that support them (see
Chapter 4). 2.17 Best Practice should be considered when
developing local policies and procedures based
Essential Quality Requirements and on the risk of surgical procedures and available
evidence. Best Practice encompasses guidance
Best Practice in decontamination on the whole of the decontamination cycle,
2.11 Essential Quality Requirements, for the including, for example, improved instrument
purposes of this best practice guidance, is a management, where there is evidence that these
term that encompasses all existing statutory and procedures will contribute to improved clinical
regulatory requirements. Essential Quality outcomes.
Requirements incorporate requirements of the
current MDD and approved Codes of Practice
as well as relevant applicable Standards. They
Developing a decontamination
will help to demonstrate that an acute care policy
service provider operates safely with respect to 2.18 In the context of this HTM,
the management and decontamination of decontamination policy is dependent on the
instruments. types of surgical procedure undertaken and
determined by the staff involved with the
2.12 Attainment of Essential Quality
management and decontamination of reusable
Requirements should also include a local risk-
surgical instruments. It is recommended that
5
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

staff conduct a local risk assessment, record 2.22 A Director of Infection Prevention and
their local policy, and adopt and develop Control (DIPC) will have ultimate responsibility
procedures appropriate to their services. The for the risk assessments. Others included in the
policies and procedures selected should meet group could be:
Essential Quality Requirements or exceed them
by achieving Best Practice. Figure 2 illustrates • the DIPC’s designated appointee;
the drivers for improvements and desired
outcomes. • the decontamination lead;

2.19 This applies to decontamination facilities • the surgical instrument manager;

on and off healthcare premises and in • representative(s) from the Infection
decontamination services managed by Control Team;
independent healthcare providers.
• representative(s) from the clinical device
2.20 For the key elements of a decontamination users;
policy, see paragraph 2.6 of ‘The Health and
Social Care Act 2008: Code of Practice’. • the User;
• an Authorising Engineer
Local determination of Best Practice (Decontamination).2.23 For a brief
summary of staffing roles and
2.21 To assess Best Practice, a local risk responsibilities, see paragraphs 6.30–
assessment group may be set up. This group 6.71.
could assess decontamination option
requirements and consider what aspects of 2.24 Others, such as representatives of
Best Practice should be implemented, based decontamination services and estates and
on improving patient outcomes, facilities, may be members of the group or co-
decontamination benefits, efficiencies and risks, opted at the discretion of the DIPC.
including those prion risks as defined by the
ACDP-TSE Subgroup.

Figure 2 Drivers for quality improvements and desired outcomes

ESSENTIAL
QUALITY
DRIVERS FRAMEWORK REQUIREMENTS ACTIONS BEST PRACTICE OUTCOMES
Scientific and
technical framework
Evidence base European Norms
and standards ISOs LOCAL CHOICE
National Decontamination
Survey Local policies and Amended theatre
procedures and decontamination
techniques
IMPROVED
Policy framework PATIENT
Patient safety 2007 clarification OUTCOMES
Health and Social Care Quality systems in place to Management of
Outcome-focus Act 2010–2012 demonstrate compliance services and clinical Continuous improvements
Risk control NICE risk-control guidance
with the Essential instruments COST
Requirements of the EFFICIENCIES
Advisory Committee Medical Devices Directive
risk-management guidance (MDD)
Audit trail of
Legal framework instruments ENHANCED
Consumer legislation Plan to work towards PATIENT
Best Practice
Patient safety
Medical Devices Directive EXPERIENCE
(EU)

Staff safety Medical Devices

Regulations (UK)
Health Act Code of
Practice

6
2 Decontamination policy for reusable surgical instruments

Implementation of HTM 01-01 leakage when combined with set colour

codes.
2.25 This guidance will help providers to
achieve a satisfactory level of risk control • Strategies for the purchase, set design
together with compliance with the essential and application of instruments used in
requirements of the Medical Devices paediatric high-risk surgery for patients
Regulations (MDR). born after 1 January 1997.

2.26 This guidance recommends that all • The development and evaluation of
providers of surgical care work with their protein detection and quantification
decontamination specialists to achieve Essential techniques for use with instruments
Quality Requirements and a locally risk- following washing and disinfection.
assessed progression to Best Practice. Not all • The maximisation of protein removal by
service providers will be in a position to adopt the use of suitably optimised washer-
Best Practice recommendations. However, disinfector and detergent systems (see
every service provider will need to: paragraphs 2.29–2.38).
• assess what Best Practice is appropriate
for each of the decontamination settings ACDP-TSE’s recommendations on
in their control, based of the surgical
procedures undertaken; protein detection
2.29 The ACDP-TSE Subgroup’s general
• what improvements they need to
principles of decontamination (Annex C) state:
undertake to move towards these; and
Protein detection
• prepare a plan for progression to Best
Practice. C21. Work commissioned by the Department of Health
indicates the upper limit of acceptable protein
contamination after processing is 5µg BSA equivalent per
2.27 All units where surgical instruments are instrument side. A lower level is necessary for
used or decontaminated should be working at neurosurgical instruments.
or above Essential Quality Requirements and
have in place local policies and business C22. It is necessary to use protein detection methods to
check for the efficient removal of protein from surgical
development programmes that demonstrate instruments after processing. Protein levels are used as
progression to Best Practice. an indication of the amount of prion protein
contamination. Ninhydrin swab kits are commonly used
2.28 This guidance has been developed and for this purpose, but recent evidence shows that ninhydrin
is insensitive. Furthermore, proteins are poorly desorbed
validated by a series of pilot studies in England from instruments by swabbing. Other commonly used
and Scotland, which looked primarily at the methods have also been shown to be insensitive.
feasibility and practicality of implementation.
Principally these include:
• Maintaining instruments in a moist
environment following use and before
reprocessing.
• The retention of surgical instruments
within their sets by the application of both
individual instruments and set level track
and trace technologies.
• Revision of set contents in neurosurgery
in order to obtain enhanced suitability for
purpose and reduced set instrument

7
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

The ACDP-TSE Subgroup’s guidance What SSDs can do to ensure

• daily testing using process challenge

devices* (along with the standard periodic Residual protein detection devices should
tests); be intended by their manufacturer to be
used as an accessory to a surgical
• quarterly residual protein testing (see instrument that has undergone a cycle
paragraphs 2.271–2.277 in HTM 01-01 through a washer-disinfector validated to BS
Part D –’Validation and verification’). EN ISO 15883 Parts 1 and 2 for washing
See also Appendix B in this document for and disinfecting of surgical invasive devices
example sampling rates. and be capable of measuring and detecting
residual protein in situ to levels of ≤5 µg per
2.34 Priority for cleaning validation and side of used, washed surgical instruments.
continuous monitoring should be given to The manufacturer will need to have CE-
instruments that have contact with high-prion- marked the product under the Medical
risk tissues as defined by the ACDP-TSE Devices Regulations and issued a
Subgroup (see Table A1 in the ACDP-TSE’s declaration of conformity to demonstrate
guidance Annex A1). that the device has met all relevant essential
requirements for the medical device and
* Commercial process challenge devices are that they have followed an appropriate
being developed whose challenge simulates conformity assessment route.
the attachment of prion protein to
instruments and whose analysis is Until such time as these are available
quantitative. When these become available as medical devices, residual protein
and have been validated, SSDs are advised control relies mainly on controlling the
to consider their use in addition to process decontamination process rather than
challenge devices based on soils in BS EN on protein detection from instruments
15883-5 Annex N. – that is, process control makes more
of a contribution than product control.
When high resolution methods of
2.35 Results from the quarterly residual protein detecting residual protein in situ are
test should be used to analyse trends and act available, then product control should
on that analysis. be used to inform process control.

Methods for detecting residual protein

Continuous improvement plans
2.36 SSDs should no longer rely on elution or
swabbing to detect residual protein on an 2.38 SSDs should have in place a plan of
instrument. The method should be validated as continuous process improvement. This plan
being able to detect protein equivalent to ≤5 µg should be carried out as part of a risk
of BSA in situ on the surface of an instrument. management plan (see BS EN ISO 14971). There
Commercial technologies that can detect the should also be a specific record that relates to
5 µg limit in situ are being developed (see residual protein trend analysis. The ambition is
ACDP-TSE’s Annex C). Methods that do not that all healthcare providers engaged in the
have protein as their target, such as ATP management and decontamination of surgical
assays, cannot be used as a substitute for instruments used in acute care will be expected
residual protein detection. to have updated their local policies and
continuous improvement plans in line with this
2.37 Devices to detect residual protein must be guidance by 1 July 2018. However, providers
CE-marked as an accessory to a medical device whose instruments are likely to come into
(see the MHRA’s ‘Managing medical devices: contact with higher risk tissues, for example
guidance for healthcare and social services neurological tissue, are expected to give this
organisations’ and also ‘Medical devices: guidance higher priority and move to in situ
conformity assessment and the CE mark’. protein detection methodologies by 1 July 2017.

9
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

3 G
uidance for commissioners, regulators and
providers

3.1 The overarching aim of the commissioning See the NHS Operating Framework for
function is to ensure the highest levels of patient further guidance on the new commissioning
care and staff safety, in the most cost-effective and management system for the NHS.
manner. In commissioning decontamination
services for surgical instruments used in acute
care, commissioning organisations should aim
to deliver: 3.2 Responsibility for achieving acceptable
standards of decontamination rests with
• sustainable high standards of patient commissioning organisations, individual trusts
safety; and provider organisations. Reprocessing units
• improved clinical care outcomes arising in healthcare establishments responsible for the
from a carefully considered local decontamination of medical devices fall into two
instrument management strategy; distinct categories when considering
compliance with the MDD:
• an enhanced patient experience through
minimising delay and procedure • Devices transferred between legal entities
cancellations associated with instrument (for example – reprocessing by one entity
provision; followed by use in another).

• cost efficiencies from instrument • Devices remaining within one legal entity
provision to the demands of the care (for example – reprocessing and use by
given; the same entity or organisation).

• local choice in the means of risk control For further information, see paragraph 4.5,
both through instrument management ‘Compliance with the Medical Devices
and in choices with regard to Regulations’.
decontamination;
• appropriate quality systems and 3.3 When commissioning surgery,
engineering standards; commissioning organisations should require
• professional work by trained managers that the healthcare provider is receiving
and staff throughout the reusable surgical devices, or it has a decontamination service,
instrument cycle. that meets the essential requirements of the
MDR and is able to demonstrate evidence of an
appropriate quality management system and
audit system.

10
3 Guidance for commissioners, regulators and providers

3.4 Commissioning organisations should also agreements. While there is sufficient flexibility in
expect the healthcare provider to have a plan in current contractual arrangements to
place to achieve Best Practice. This plan should accommodate the HTM approach, the
have been developed, having taken account of development of local policies and procedures
the risk of surgical procedures (see paragraph may require locally negotiated variations to the
2.18 and Chapter 5). Commissioning contract to accommodate changes to the
organisations may use this plan to improve the service specification. There are two routes to
services commissioned from providers for the vary the contracts let through the National
benefit of patients, and to differentiate between Decontamination Programme: via schedule 11
providers. and schedule 21 of the Decontamination
Services Agreement. For other third-party
3.5 They may do this by: contracts, advice would have to be sought
locally on the mechanism for implementing
• including the attainments within the changes.
service specification element of the
standard contract;
Implication for third-party providers
• establishing key performance indicators
as part of a tendering process; and 3.11 Where decontamination services are
provided by a third party, all parties to the
• using Best Practice as an incentive to service should work together to develop local
improve provider performance. policies and procedures that are appropriate
and can be implemented.
3.6 Best Practice could also be used as
attainment levels against which improvements 3.12 It should be noted that third-party
can be measured and rewarded, enabling providers of decontamination services come
commissioners to encourage evidence-based under the MDD (directive 93/42/EEC has been
practices and innovation. superseded by directive 2007/47/ EC). They will
be using existing British and European
3.7 Providers may refer to paragraph 2.11 in Standards to demonstrate compliance with the
order to assess the quality of their essential requirements of the MDD and will
decontamination services and demonstrate have a quality system against which they are
quality improvement within their organisation. independently audited. The development and
implementation of new local policies and
3.8 In the event of poor performance,
procedures may require a variation to the
commissioners may discuss the level of
contract and changes to quality systems to
performance with their providers and address
accommodate.
any issues and concerns before introducing
more formal contractual remedies.

3.9 Regulators may use the recorded risk-

assessed local policy to check Essential Quality
Requirements attainments alongside adherence
to regulatory requirements.

Implication for contractual

agreements
3.10 The adoption of a risk-control based
approach to surgical instrument management
should not prejudice current contractual

11
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

4 Regulatory framework

4.1 This chapter sets out the duty of care for 4.7 Irrespective of this, however, the standards
decontamination services in England. The applied to all organisations that provide
regulatory framework is applicable across all decontamination services are monitored
sectors of healthcare (see Figure 3). against the essential requirements of the MDD.
This is undertaken either by a notified body,
whose activities are monitored by the MHRA if
European legislation the formal certification route is applied, or by
4.2 There are three EU Directives relating to the the CQC.
manufacture and supply of medical devices:
4.8 Figure 4 illustrates the regulatory framework
• MDD 93/42/EEC and the compliance routes for reusable medical
• In-vitro Diagnostic Devices Directive devices transferred between legal entities and
98/79/EEC for reusable medical devices remaining within
one legal entity.
• Active Implantable Medical Devices
Directive 90/385/EEC. Compliance with the MDD
4.3 These three directives have been 4.9 Responsibility for achieving acceptable
transposed into UK law as the Medical Devices standards of decontamination rests with
Regulations (MDR) 2002, as amended. (For commissioners, individual trusts and provider
more information about the MDDs and organisations.
compliance, visit the MHRA’s website.)
4.10 Healthcare organisations decontaminating
4.4 Washer-disinfectors and sterilizers – that is, reusable medical devices fall into two distinct
those machines specifically intended for the categories when considering compliance with
decontamination of reusable medical devices the MDD:
– can also fall within the scope of the MDR.
• reusable medical devices transferred
between legal entities
Compliance with the Medical • reusable medical devices remaining
Devices Regulations within one legal entity.
4.5 Only those units that transfer reusable
4.11 The requirement for formal certification of
medical devices are within the scope of the
SSDs under the MDD is dependent on whether
MDD and the MDR.
“product” is “placed on the market”. Providing
4.6 Devices decontaminated for reuse are not products to another legal entity is “placing
“placed on the market” and are therefore product on the market”.
outside the scope of the regulations.
4.12 The implications of the MDD regulations
are that all those organisations that provide

12
4 Regulatory framework

Figure 3 Overview of the interaction between the different structures within the English legislative system

English Legislation (this is not an exclusive list)

• Health and Social Care Act 2008 (Regulated Activities) Regulations
2014
European Legislation
(eg European Directives) • Care Quality Regulations 2009
• Medical Devices Directive 93/42/EEC

Codes of practice
Regulations and
• Health Act 2009
• In-Vitro Diagnostic Devices Directive1
• Active Implantable Medical Devices Directive1 • Health and Safety at Work etc Act 1974
• Consumer Protection Act 1997

Regulations and Codes of Practice relating to the manufacture and supply of medical devices and reprocessing
equipment
• Medical Devices Regulations 2002
• Pressure Systems Safety Regulations 2000 (as amended)
• Control of Substances Hazardous to Health Regulations 2002 (as amended)
• Personal Protective Equipment at Work Regulations 1992 (as amended)
• The Health and Social Care Act 2008: Code of Practice on the prevention and control of infections and related guidance

British, European and International Standards Healthcare Standards

Standards
Regulatory bodies
• Medicines and Healthcare products Regulatory
Agency (MHRA) Regulatory bodies
• Notified bodies • Care Quality Commission

Guidance

•D H Guidance (HTMs and Health Building Notes

such as HBN 13)
•M HRA guidance (safety notices, alerts and Notes
bulletins) 1. The In-Vitro Diagnostic Devices and Active
• NICE guidance (e.g. NICE196) Implantable Medical Devices Directives have been
• ACDP-TSE guidance included for completeness although these devices
are usually supplied sterile and are single-use.

decontamination services and which “place provides a standardised approach to

product on the market” are legally required to decontamination in the UK and across all
demonstrate compliance to the harmonised European countries.
standards contained within the directive. It

13
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Figure 4 Regulation and audit of decontamination services and the respective responsibilities of MHRA and CQC

Regulation and audit of decontamination services

Decontamination carried out off-site Decontamination carried out on-site

(for example, sterile services super centre, (for example, a trust or other healthcare organisation
a trust carrying out decontamination on behalf of has its own sterile services department on-site)
another trusts ot trusts)

Regulation by MHRA Regulation by CQC

Audit by a notified body Local self-audits by provider

with judgement about compliance by CQC

4.13 The most commonly used route to another legal entity are subject to the
demonstrating compliance is to institute a requirements of the MDR. If sterile devices are
quality management system such as BS EN produced, the intervention of a third-party audit
ISO 13485 across all areas of the programme must also be undertaken by a
decontamination cycle. recognised notified body.

4.14 BS EN ISO 13485 specifies requirements 4.16 A notified body is a certification

for a quality management system that can be organisation that the competent authority
used by a healthcare organisation for the (MHRA within the UK) designates to carry out
design and development, production, one or more of the conformity assessment
installation and servicing of reusable medical procedures described in the annexes of the
devices and the design, development and MDD.
provision of related services. It can also be
used by internal and external parties, including 4.17 Healthcare organisations “placing product
certification bodies, to access the healthcare on the market” must also register with the
organisation’s ability to meet customer and MHRA.
regulatory requirements. Its primary objective is
4.18 Commissioners should be provided
to facilitate reusable medical device regulatory
access, if required, to check that a provider is
requirements for quality management systems.
registered with a notified body and has an
appropriate quality system in place.
Reusable medical devices transferred
between legal entities 4.19 Commissioners should be given access to
4.15 Healthcare organisations offering the the results of the most recent third-party
decontamination of reusable medical devices to (notified body) audit and should be able to see
any:
14
4 Regulatory framework

• non-conformances picked up in the The Health and Social Care Act

audit;
2008: Code of Practice
• required corrective actions that have 4.25 The guidance provided here is consistent
been agreed; and with the ‘Health and Social Care Act 2008:
• evidence of corrective actions being Code of Practice on the prevention and control
implemented. of infections and related guidance 2010
revision’ (‘the Code’). The Code recommends
that effective prevention and control of
Reusable medical devices remaining within
healthcare-associated infections be embedded
one legal entity
in everyday practice. For this reason, the
4.20 If a healthcare organisation only provides guidance is written with emphasis on practical
decontaminated reusable medical devices for and readily implemented measures.
use on, or by, patients of that same entity (that
is, there is no ”placing on the market”), the 4.26 Adhering to this HTM will assist providers
MDR do not apply. in complying with the decontamination
guidance set out in the Code and in meeting
4.21 These healthcare organisations do not the CQC registration requirement on hygiene
need to register with the MHRA nor do they and infection control.
need to use a notified body; nevertheless, they
are subject to the duty of care imposed under Key Code recommendations
product liability. They must still ensure
instruments are safe, fit for purpose and of 4.27 With a view to minimising the risk of
suitable quality. The CQC will assess the infection, a registered provider should normally
performance of these organisations. ensure that it designates leads for
Registration with the CQC includes a number of environmental cleaning and decontamination of
requirements in this area, and providers are equipment used for diagnosis and treatment (a
required to comply with these requirements. single individual may be designated for both
areas).
4.22 Compliance with BS EN ISO 13485 will
demonstrate a commitment to producing 4.28 The decontamination lead should have
reusable medical devices of appropriate quality. responsibility for ensuring that policies exist and
that they take account of best practice and
national guidance for the decontamination of
Outsourcing reusable surgical instruments.
4.23 The options for those healthcare
organisations that do not undertake 4.29 The decontamination policy should
decontamination services include: demonstrate that:

• Using a decontamination service that is • it complies with guidance establishing

registered with the MHRA, that is Essential Quality Requirements and a
compliant with the MDR, and that uses a plan is in place for progression to Best
notified body as its third-party auditor. Practice;

• Using CE-marked single-use medical • decontamination of reusable medical

devices. devices takes place in appropriate
facilities designed to minimise the risks
4.24 The relative merits of the options should that are present;
be evident through developing a business case • appropriate procedures are followed for
highlighting the options, timescales, cost the acquisition, maintenance and
benefits and reliability assessment. validation of decontamination equipment;

15
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

• staff are trained in cleaning and 4.33 Although compliance with a mandated
decontamination processes and hold standard is not the only way of complying with
appropriate competences for their role; the directives, it is the simplest.
and
4.34 The list of standards given in Appendix A
• a record-keeping regime is in place to
is not exhaustive but includes the key
ensure that decontamination processes
documents that may be used to inform the
are fit for purpose and use the required
management of decontamination of reusable
quality systems. (See also Outcome 11,
medical devices in a healthcare organisation.
Regulation 16 Safety, availability and
See also the website of the European Union.
suitability of equipment contained in CQC
Guidance about compliance.)
Policy and guidance
Care Quality Commission 4.35 The DH and other professional bodies and
advisory committees have published guidance
4.30 The CQC independently regulates all
on the decontamination of surgical instruments.
providers of regulated health and adult social
The list below is not exhaustive but includes the
care activities in England. The CQC’s (2015)
key resources that may be used to inform the
‘Guidance for providers on meeting the
management of decontamination within a
regulations’ explains how to meet regulations
health service environment:
12(2)(h) (on safe care and treatment) and 15
(safe premises and equipment) of the Health • The DH’s HTM series.
and Social Care Act 2008 (Regulated Activities)
Regulations 2014. • For a list of medical device alerts, safety
notices, hazard notices and device
4.31 Failure to comply with the Health and bulletins relating to decontamination, visit
Social Care Act 2008 (Regulated Activities) the MHRA’s website.
Regulations 2014 and the Care Quality
Commission (Registration) Regulations (2009) is 4.36 The DH’s policy is that the measures
an offence, and the CQC has a wide range of defined in NICE IPG 196 (2006) guidance be
enforcement powers that it can use if a provider incorporated into practice and supplemented
is not compliant. These include the issue of a by the guidance derived from the ACDP-TSE
warning notice that requires improvement within Subgroup:
a specified time, prosecution, and the power to • the ACDP-TSE Subgroup provides
cancel a provider’s registration, removing its practical scientifically based advice on
ability to provide regulated activities. the management of risks from TSEs in
order to limit or reduce the risks of
British, European and International human exposure to, or transmission of,
TSEs in healthcare and other
Standards occupational settings.
4.32 To support the MDD and to assist
• NICE IPG 196 (2006) provides guidance
manufacturers (including decontamination
on how best to manage the risk of
services) to interpret the essential requirements,
transmission of CJD and vCJD via
the European Commission has published an
interventional procedures. This was the
updated list of harmonised standards.
subject of CMO Letters recommending
Compliance with all relevant harmonised
the implementation of NICE IPG 196
standards on this list leads to an automatic
(2006) and is DH policy.
presumption that the medical devices comply
with the requirements of the MDD.

16
5 Human prion diseases (including variant CJD and other forms of CJD)

5 Human prion diseases (including variant CJD

and other forms of CJD)

Background
The human prion diseases are a group of rare fatal neurological disorders that occur in sporadic,
genetic and acquired forms, the latter occurring by transmission from one individual (or species)
to another. These conditions are all associated with the conversion of a normal protein in the
body, the prion protein, to an abnormal disease-associated form that accumulates in the brain
and results in neuronal degeneration and death. The abnormal prion protein is thought to be the
major component of transmissible prion agents.

The commonest human prion disease is the sporadic form of Creutzfeldt-Jakob disease (sCJD),
with an annual incidence worldwide of one-to-two cases per million of the population. In the UK,
there are between 50 and 90 cases annually, with a peak incidence in the 60–70-year age
group. This disease presents with rapidly progressive dementia and a range of other
neurological signs and symptoms, with death occurring in around three-to-six months of disease
onset. The genetic forms of human prion disease account for around 10% of total cases, while
acquired cases are account for around 1%, including iatrogenic CJD (iCJD) in human growth
hormone and dura mater graft recipients, and variant CJD (vCJD). Incubation periods in
acquired human prion diseases can vary from two to over 40 years, depending on the route of
exposure. vCJD was first reported as a novel human prion disease in 1996, acquired from
infection by the bovine spongiform encephalopathy (BSE) agent, most likely via the oral route.
Patients with sCJD and vCJD have differences in the distribution of prion infectivity around the
body. In sCJD (and also in some cases of genetic prion diseases and iCJD), abnormal prion
protein appears to be restricted to the central nervous system (CNS), whereas in vCJD it has
also been detected in lymphoid tissues, including tonsils, spleen and gastrointestinal lymphoid
tissue. Abnormal prion protein has been detected in the lymphoid tissues of a few individuals
infected with vCJD before the onset of clinical signs and symptoms of the illness, indicating
asymptomatic vCJD infection.

vCJD is distinguishable from non-vCJD in a number of ways:

• It tends to affect younger people with an average (median) age of onset of around 26
years (median age at death 28 years).
• The predominant initial clinical symptom is of psychiatric or sensory problems, with
coordination problems, dementia and muscle-twitching occurring later.
• The illness usually lasts about 14 months (range 6–84 months) before death.

A definitive diagnosis of vCJD can only be confirmed by examining brain tissue, usually at post-
mortem, and requires the exclusion of other forms of human prion disease, particularly sCJD.

17
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

In the UK, as of 2016, there have been 177 deaths from definite or probable cases of vCJD,
three of which appear to have been acquired by packed red blood cell transfusion from infected
donors. The peak year of deaths was 2000, since when numbers of cases have fallen
progressively with no new cases reported since 2012. However, given the long incubation
periods previously seen for acquired CJD, and with evidence from tissue-based prevalence
studies in the general population, the potential for further cases to emerge or for potential
asymptomatic abnormal prion carriage within the general population has yet to be ruled out.

While three vCJD cases may have been transmitted by blood transfusion, there are no known
cases of vCJD being transmitted by surgical instruments or endoscopes. However, it may be
possible because:
• sCJD has been transmitted by neurosurgical instruments used on the brain;
• abnormal prion protein binds avidly to steel surfaces and can be very difficult to remove
from surgical instruments; and
• prion infectivity has been found in a range of tissues (brain, spleen, tonsils etc) of patients
who have developed symptomatic vCJD

Guidance from the Advisory Committee on Dangerous Pathogens Transmissible Spongiform

Encephalopathy (ACDP-TSE) Subgroup, formerly the TSE Working Group, details precautions to
be taken when dealing with known or suspected cases and those at increased risk of human
prion disease.

What is the relevance of decontamination to human prion diseases?

While there is still a good deal of scientific uncertainty about human prion diseases, the DH
continues to take a precautionary approach and adapt policy as new evidence emerges. To
maintain effective risk management, it is important to combine improved recognition of
potentially infected individuals who are at increased risk of human prion disease with the most
effective methods for surgical instrument decontamination.

inactivate by conventional decontamination

processes.
Introduction
5.1 The human prion diseases (including sCJD 5.3 Abnormal prion protein may accumulate to
and vCJD) are a group of rare invariably fatal very high levels in the CNS of all patients with a
neurological disorders. In these diseases the human prion disease (including sCJD and
normal human prion protein in the body vCJD). For this reason, the CNS is considered
undergoes misfolding to become an abnormal as a high infectivity tissue in all forms of human
disease-associated protein, which is the major prion disease.
component of the transmissible agents in prion
diseases. 5.4 In vCJD, abnormal prion protein also
accumulates at lower levels in lymphoid tissues
5.2 Abnormal prion protein is heat-stable, (for example tonsils, spleen, lymph nodes and
exceptionally resistant to enzymatic digestion Peyer’s patches in the gastrointestinal system).
and, once dried onto surfaces of surgical This accumulation appears to begin before the
instruments, is very difficult to remove or onset of clinical symptoms of vCJD and may
therefore indicate asymptomatic vCJD infection.

18
5 Human prion diseases (including variant CJD and other forms of CJD)

Lymphoid tissues are considered medium 5.9 Part 4 also describes:

infectivity tissues in vCJD (but not in sCJD and
most other human prion diseases). • The range of tissues for which surgical
instrument precautions should be taken
5.5 This HTM supports commissioners and (“Tissue infectivity”, paragraph 4.12).
providers in implementing appropriate and
• Recommendations for single use
effective decontamination measures to reduce
instruments; handling of reusable
the risks of transmission of human prion
instruments; and instrument disposal
diseases. Owing to the difficulty of inactivating
(“Surgical procedures and instrument
or removing human prion proteins from surgical
management”, paragraph 4.46). Advice is
instruments, special measures are required to
set out separately for patients at risk of
prevent their potential transmission between
sCJD, iCJD and inherited prion disease
patients.
and those at risk of vCJD due to the
5.6 Guidance on the relative risk of different larger range of tissues involved in vCJD
body tissues can be found in the ACDP-TSE (tables 4c and 4d).
Subgroup’s Annex A1. Patient risk assessment • Advice on the procedures to be followed
and procedures can be found in Annex J. See for quarantining surgical instruments is
also Public Health England’s CJD section. given in Annex E of the guidance. Under
no circumstances should quarantined
Patients with CJD, suspected CJD instrument sets be used on other patients
unless the diagnosis of CJD or vCJD has
or an increased risk of developing been positively excluded.
CJD
5.10 All instruments should be kept moist prior
5.7 The ACDP-TSE Subgroup’s guidance on to being sent for reprocessing. There are a
minimising the transmission of CJD and vCJD variety of methods, for example gels, sprays
in healthcare settings provides advice on the and use of wet towels, that could be applied to
use and management of surgical instruments keep instruments moist; the choice of the exact
for procedures where there may be a risk of method used rests with the decontamination
surgical transmission. manager, Decontamination Lead or local
Infection Control Team following risk
5.8 This advice applies to:
assessment.
• patients with probable or confirmed CJD;
5.11 The instrument set should be reprocessed
• those for whom CJD is being considered through the SSD in the usual manner. No
as a differential diagnosis; and special precautions are necessary as proteins
• around 5000 people who: lifted by detergent action from the surface of a
contaminated instrument will not deposit on
−− have an increased risk of CJD other surfaces in the washer-disinfector. The
because of an operation or medical possibility of residual abnormal prion on the
treatment in the past, or instruments is of far greater concern than the
possibility of contamination of instruments in
−− are at risk of inherited prion disease. other sets processed in the washer-disinfector
either concurrently or subsequently.
Detailed descriptions and definitions of these
risk groups can be found in paragraph 4.17 5.12 A traceability system for equipment
(“Patient categorization”) of the ACDP-TSE’s especially where used on patients with, or at
Part 4 – ‘Infection control of CJD, vCJD and increased risk of, human prion disease is very
other human prion diseases in healthcare and important. Also subsequent storage (including
community settings’.

19
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

quarantine if indicated) or use of instruments Prion-specific decontamination

must be recorded and where appropriate
specialist advice obtained from the local Health
technologies
Protection Team. 5.15 There are technologies that may offer
future potential to enhance the existing
5.13 For details about action required following decontamination process to reduce protein,
invasive procedures on a patient with definite or including prion protein contamination of
probable vCJD or presumed infected cases, instruments.
see also Public Health England’s ‘CJD: public
health action following report of new case or 5.16 In addition to activity against abnormal
person at increased risk’. prions, prion decontamination technologies
must also:
Protein removal and detection a. be compatible with the existing
decontamination processes;
5.14 Guidance on protein removal and
detection is given in paragraphs 2.29–2.38. b. remove protein;
c. have good stability;
Note
d. have acceptable environmental and
This remains a work in progress which will operator safety;
be updated as additional evidence becomes
e. be compatible with instruments and
available.
EWDs.

20
6 Management of surgical instruments

6 Management of surgical instruments

Introduction Keeping instruments moist between

6.1 This chapter aims to provide further use and reprocessing
guidance on the management of surgical 6.5 Prions are hydrophobic proteins. The
instruments to support further risk reduction attachment of hydrophobic proteins to surfaces
and improvements to patient outcomes. becomes less reversible if they are allowed to
dry fully. Keeping the environment around
6.2 Management of surgical instruments in
soiled instruments at or near saturation
HTM 01-01 relates to those used in acute care.
humidities (moist) prevents full attachment of
In this context, management of surgical
hydrophobic proteins such that they are more
instruments should make sure that risks
efficiently removed by cleaning.
associated with surgical procedures are
minimised. 6.6 A number of means are available to
generate moist conditions, including the use of
6.3 The following management choices have
enclosed containers/bagged trays used with
been identified:
single-use moist pads, gels, foams, water
• keeping instruments moist; sprays or other methods as determined locally.
• separation of instruments used on high 6.7 However, whatever method is used, care
risk tissues for patients born before and should be taken to ensure that all parts or
after 1 January 1997; surfaces of the surgical instruments are
constantly exposed to the moist environment.
• instrument audit and tracking.

6.4 Other management choices covered in this Separation of instruments used on

guidance include:
high risk tissues for patients born
• loan sets;
before and after 1 January 1997
• loan sets used in high-risk surgical 6.8 It is thought that people born since
procedures; 1 January 1997 have had lower exposure to
• repairs; prions via the food chain. These people form a
group at lower risk of prion diseases and thus
• instrument audit and tracking policy; at a lower risk of contaminating surgical
instruments with prions. The NICE IPG 196
• single-use instrument tracking and
(2006) risk-reduction strategy requires that
records;
separate pools of instruments be used for high-
• decontamination of surgical instruments risk tissue surgery, dependent on the patient’s
that have been dropped perioperatively. birth date. This differentiates between patients
who were either born before 1 January 1997, or
who were born on or after 1 January 1997, and

21
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

requires that separate pools of instruments be 6.10 If instruments from the reserved post-1996
used for each stream. stock are used deliberately or by mistake in a
patient born before 1997, they should not be
6.9 There will be a small number of patients returned to the post-1996 stock, but may
born after 1 January 1997 who were operated continue to be used as part of the pre-1997
on using pre-1997 instruments before the 2006 stock (see Figure 5). The same age separation
NICE guidance was issued. For these patients, should be applied to loan sets.
further high-risk tissue surgery should use
either:
Loan sets
• single-use instruments, provided these
are available and of satisfactory quality; or 6.11 Instrument sets that are supplied from an
external source, used for that procedure only
• new reusable instruments, or post-1996 and then returned are known as loan sets. This
instruments and either: practice increases the risks associated with the
−− retain them for sole use on this decontamination and reprocessing of such
patient; or instruments, because the organisation may not
be familiar with them. Organisations have also
−− afterwards add to the pre-1997 expressed concern over the decontamination
stock1. status of such instruments and the lack of track
and traceability, including potential for
instrument migration. It is a requirement of the

Figure 5 Instrument stock identification for high-risk tissue surgery

Born after Use pre-1997 Return

1 January stock of instruments to
1997? No instruments pre-1997 stock

Yes
Use single-use
instruments
Previous high-risk
tissue surgery Use new
performed prior to reusable Retain instruments
implementation of Yes instruments for sole use on
NICE IPG 196? this patient
or
No Use post- add to pre-1997
1996 stock of stock
instruments
Use post- Return
1996 stock of instruments to
instruments post-1996 stock

1 This reflects guidance by the Society of British Neurological

Surgeons and the ACDP-TSE Subgroup in preparation at the time
of publication of this HTM.

22
6 Management of surgical instruments

Code of Practice that reusable medical devices 6.15 Theatre staff and SSDs should take
should be decontaminated in accordance with special care to ensure integrity of loan sets and,
manufacturers’ instructions. Therefore, loan for instruments used on high risk tissues, their
sets should be provided with decontamination membership of pre or post 1 January 1997
instructions so that staff can ensure their instrument groups from receipt to dispatch.
compatibility with local decontamination
processes. It should be ensured that when
equipment is supplied to a healthcare provider, Repairs
adequate time is allowed for cleaning, 6.16 Any instrument used on high risk tissues
sterilization and return of the equipment to the that are removed for repair should be returned
theatres, both prior to and after use (see the to the instrument set from which it was
AfPP’s (2010) guidance ‘Loan set management removed.
principles between suppliers/manufacturers,
theatres & sterile service departments’ and
MHRA’s ‘Managing medical devices’). Instrument audit and tracking
6.17 There is a need to track and trace reusable
6.12 Set integrity needs to be maintained to
surgical instruments throughout their use and
minimise instrument migration and enable
reprocessing. This is to avoid instrument
traceability to the patient. This extends to the
migration and is an essential requirement of the
control of individual instruments within loaned
MDR and the Code of Practice.
sets, to audit their removal and replacement.
6.18 Records should be maintained for all the
Loan sets used in high-risk surgical instrument sets (and supplementaries for high-
risk procedures) identifying:
procedures
• the cleaning and sterilization method
6.13 Particularly for high risk surgical
used
procedures (see Chapter 5), healthcare
providers using loan sets should ensure that • a record of the decontamination
records of such sets are maintained within their equipment and cycle
control. These records should be available for
independent review and should, at a minimum, • the identity of the person(s) undertaking
make it possible to ascertain the details of the decontamination at each stage of the
instruments contained within the set and the cycle
surgical units within which the set has been • the patients on whom they have been
used. Dates and session times for each use used and details of the procedures
should also be recorded. The identity of involved.
patients with whom the sets have been used
should be traceable from the record but, for 6.19 This information is required so that
patient confidentiality, maintained within the instrument sets (and supplementaries for high-
secure environment of the clinical service risk procedures) and the patients they have
providers concerned. been used on can be traced and the instrument
sets and supplementaries recalled when
6.14 Instruments within loan sets shall be necessary.
subject to quality system and control measures
at least equal to those normally applied in the 6.20 The reunification of instruments with their
surgical centres where they are used. This sets following repair or replacement benefits
applies equally when surgeons or other team from accurate instrument identification. Tracking
members are the sponsor of any loan is likely to mitigate other factors, including those
arrangement. associated with operative failure due to the
absence of key instruments or arising from poor

23
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

adherence to scheduled instrument Decontamination of surgical

maintenance – particularly those which have
electrical components.
instruments that have been
dropped perioperatively
6.21 For those instruments, including delicate
6.25 Instruments dropped or which otherwise
components such as electronic devices or
have their sterility compromised during use
imaging related markers, the use of single
should be replaced. There should, where
instrument identification may be of special
standard sets are being used, always be at
value. When marking is combined with properly
least one readily accessible spare set so this
managed decontamination procedures the
can happen with minimal delay. The local policy
individual instrument may be correctly identified
to ensure this occurs efficiently should be
as requiring a non-standard approach to
established with the theatre users, the theatre
washing, disinfection or sterilization.
manager and the DIPC (or their nominee). This
6.22 Individual instruments may have may on rare occasions not be possible, for
warranties associated with them which carry a example if use of loan sets does not allow this.
guarantee. However if the individual warranted
6.26 On these occasions, a local risk
instrument cannot be reliably identified to a
assessment by the operating team should
standard which is satisfactory to the supplier,
assess the relative risks of the options available,
then it is unlikely that the warranty can be
for example: the continuation of the procedure
evoked. A similar argument applies to
without that item; the abandonment of surgery;
instruments such as arthroscopy scissors,
the return of that item to the SSD for full
which are limited in terms of the number of use
decontamination.
cycles, authorised by the manufacturer under
CE marking. 6.27 Current DH policy remains to reduce
inappropriate local reprocessing such as the
6.23 NICE IPG 196 (2006) guidance requires
use of non-compliant, non-validated bench top
that high-risk tissue instrument sets used with
sterilizers. Development of local policies and
patients born since 1 January 1997 form a pool
procedures needs to consider benefits, risk and
within which instruments must be retained and
cost of the options available.
from which other instruments must be
excluded. This is challenging when 6.28 Where benchtop sterilizers are still
supplementary instruments are used. Teams available, these should be a last resort, and
are likely to find effective streaming of non- instruments should be subject to local manual
marked instruments difficult. The use of larger cleaning to an agreed procedure. The
sets which include supplementary instruments unwrapped item should be processed in a
will partly mitigate this risk, particularly when downward displacement steam sterilizer
combined with instrument marking, tracking maintained and validated including undertaking
and audit techniques. the necessary daily automatic control tests

6.29 There should be measures in place to

Single-use instrument tracking and audit each use of this sterilizer and identify
records which cycles are for the sterilizer’s routine
6.24 When single-use surgical instruments are validation and which are for surgical instrument
used, they must be separated from reusable decontamination. This audit should ensure that
surgical instruments and disposed of at the end the sterilizer is only used for instrument
of the procedure. It is important that the single- decontamination in the exceptional
use instruments are not allowed to enter circumstances outlined above. It should be
reusable instrument sets. appreciated that this should be a last resort
and should be reported through the hospital’s
adverse incident report system.
24
6 Management of surgical instruments

Staff roles and responsibilities 6.30 Staff undertaking decontamination and

management of decontamination should be
Note: able to demonstrate their competencies and
training in this area through individual training
One of the recommendations arising from a records, detailing the appropriate core
survey of decontamination services in competencies and any other supplementary
England undertaken by the Department of training. These records should be updated at
Health in 2000 was that “all staff, including least annually. Line or training managers should
managers, directly or indirectly involved in be responsible for maintaining these records.
decontamination of surgical instruments to
be competent on the basis of appropriate 6.31 The approach adopted in this HTM is to
education, training, skills and experience.” identify the distinct functions that need to be
exercised and the responsibilities that go with
Furthermore, the Health and Social Care Act them. The titles given are therefore generic;
Code of Practice on the prevention and they describe the individual’s role in connection
control of infections states that with decontamination but are not intended to
decontamination policies should be prescriptive job titles for terms of
demonstrate that “staff are trained in employment. Indeed, many of the personnel
cleaning and decontamination processes referred to may not be resident staff but
and hold appropriate competencies for their employed by outside bodies and working on
role”. contract. Some of them will have other
responsibilities unconnected with
The ACDP-TSE Subgroup therefore decontamination and in some cases the same
recommends that decontamination staff individual may take on more than one role.
should undertake appropriate formal
training: for example, the training package 6.32 Whatever model of operational
offered by the Institute of Decontamination management is chosen, the roles and
Sciences (IDSc) in conjunction with Anglia responsibilities of the individuals involved should
Ruskin University, or other equivalents such be clearly defined and documented. In every
as the training programmes being case, however, it should be possible to identify
developed under the Modernising Scientific a User who is responsible for the day-to-day
Careers initiative. It also suggests that, management of the decontamination of
although there is no current professional reusable surgical instruments. The philosophy
registration of decontamination personnel, it of this HTM is to invest the User with the
would be best practice for senior SSD staff responsibility for seeing that the
(for example the User) to be members of a decontamination process is operated safely
relevant professional body such as the IDSc. and efficiently.

All medical device decontamination 6.33 The following personnel are referred to in
sciences staff are aligned to the national this HTM.
profiles for healthcare science. Implementing
the generic job descriptions (JDs) for Management – definition
medical device decontamination sciences
staff will improve patient safety and staffing 6.34 Management of a healthcare organisation
structures within medical device performing decontamination is defined as the
decontamination sciences departments – owner, chief executive or other person of similar
example generic JDs are available on the authority who is ultimately accountable for the
IDSc website. safe operation of the premises, including
decontamination.

25
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

• Executive Manager (for example, chief responsibility for decontamination, either at

executive); board level or who has line management
responsibility to a senior responsible person at
• Decontamination Lead (this person may that level.
also act as the Designated Person if
locally agreed); 6.38 The Decontamination Lead should report
• Designated Person directly to the Executive Manager.

• Surgical Instruments Manager 6.39 The Decontamination Lead is

organisationally responsible for the effective,
• Senior Operational Manager (for example, and technically compliant, provision of
estates manager); decontamination services.
• User (for example, sterile services
manager); 6.40 The Decontamination Lead is responsible
for the implementation of operational policies
• Authorising Engineer (Decontamination); for decontamination and should ensure specific
operational policies are in place for the
• Authorised Person (Decontamination); decontamination of all medical devices. He/she
• Competent Person (Decontamination); should ensure that the operational policy clearly
defines the roles and responsibilities of all
• Director of Infection Prevention and personnel who may be involved in the use,
Control (in England); installation and maintenance of
• Infection Control Doctor; decontamination equipment. The
Decontamination Lead is also responsible for
• Microbiologist (Decontamination); monitoring the implementation of the policy and
should have a competent understanding of the
• Operator; decontamination of medical devices, guidance,
• Manufacturer; legislation and standards.

• Contractor; 6.41 The Decontamination Lead may delegate

specific responsibilities to key personnel; the
• Purchaser;
extent of such delegation should be clearly set
• Competent Person (Pressure Systems). out in the operational policy together with the
arrangements for liaison and monitoring.
Executive Manager
6.42 The Decontamination Lead may also act
6.35 The Executive Manager is defined as the as the Designated Person.
person with ultimate management
responsibility, including allocation of resources Designated Person
and the appointment of personnel, for the
organisation in which the decontamination 6.43 This person provides the essential senior
equipment is installed. management link between the organisation and
professional support.
6.36 Depending on the nature of the
organisation, this role may be filled by the 6.44 The Designated Person should also
general manager, chief executive or other provide an informed position at board level.
person of similar authority.
6.45 The Designated Person should work
closely with the Senior Operational Manager to
Decontamination Lead ensure that provision is made to adequately
6.37 Every healthcare provider should have a support the decontamination system.
nominated Decontamination Lead with
26
6 Management of surgical instruments

Surgical Instrument Manager/coordinator • oversee the audit process for instrument

sets from procurement through use,
Note: decontamination and final disposal;
• ensure instrument sets never used are
This role can be fulfilled by the User. reviewed and/or disposed of;
• oversee actions to provide a mechanism
6.46 The decontamination manager of surgical for routinely revalidating instrument-set
instruments (medical devices) or other content (for example, annual sign off of
designated person should be assigned by the the tray checklist by surgical teams);
Decontamination Lead to take responsibility for • ensure the leakage of surgical
coordinating activity between the theatre, instruments between sets is minimized by
decontamination and supply/purchase teams. effective process mapping using
The person fulfilling that role should also ensure recommended audit procedures, post-
that the inventory of surgical instruments is operative checks, the signing of tray
proactively reviewed and managed in checklists by theatre sister, and
accordance with this guidance, clinical decontamination facility processing
requirements and industry best practice. techniques (that is, specific instrument
set contents are kept together throughout
6.47 Specifically, this officer will: the decontamination cycle);
• make judgements on the suitability of • ensure instrument sets with observed
reusable instruments in consultation with missing or damaged content are updated
surgical teams and those responsible for through targeted investment ensure the
decontamination. This work will be healthcare organisation has documented
assisted by the formation of a working policies in place for the operational
group for ongoing collaboration; management of its instrument-set
• determine appropriate instrument-set inventory; these should include policies
structures designed to assist in the on (as a minimum);
prevention of leakage of instruments • manage the loaning of instrument sets to
between sets (including preventing the and from external suppliers using the
movement of supplementary instruments audit techniques given in this guidance;
between sets) in consultation with clinical
• purchase new instrument and sets
specialists and decontamination teams;
(including, as a minimum, the
• ensure that guidance on tracking and documented approval of the theatre
traceability is appropriately applied to all team, decontamination specialists and
instruments (this includes loan sets) and Control of Infection lead);
collaborate with those responsible for
• ensure repaired instruments are returned
patient records to ensure any patient with
to the original instrument set;
whom they are used can be identified
and linked to the sets or individual • oversee a standardised approach to
instruments used; instrument nomenclature throughout the
healthcare organisation;
• ensure that missing or damaged surgical
instruments are replaced preserving the • ensure all Instrument sets have an
appropriate set structure; accurate version-controlled checklist
validated by the surgical team (preferably
• oversee the monitoring of condition and
in an electronic format);
suitability for surgical instruments;
• determine that all Instrument stores
(including wards and departments) are

27
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

audited on a regular basis, and all • to ensure that decontamination

redundant items removed from equipment is subject to periodic testing
circulation; and maintenance;
• ensure a mechanism is in place for • to appoint operators where required and
addressing instrument set usage non- ensure that they are adequately trained;
conformities such as wet packs, torn tray
wrap etc.; • to maintain production records;
• provide and oversee mechanisms to • to establish procedures for product
ensure all instruments in the healthcare release in line with the quality
organisation’s inventory are fit for purpose management system;
(for example regular review of appropriate
records); • to ensure that procedures for production,
quality control and safe working are
• ensure the healthcare organisation holds documented and adhered to in the light
an accurate database of its instrument- of statutory requirements and accepted
set inventory including tray type, location best practice.
of use and stock level;
• ensure all instruments sets which are 6.52 The User may seek the advice of infection
critical in stock levels are risk assessed, control teams, which may consist of a DIPC,
to maximize patient safety and inform Infection Control Doctor or Microbiologist
instrument set investment. (Decontamination).

Senior Operational Manager Authorising Engineer (Decontamination)

(AE(D))
6.48 The Senior Operational Manager is
technically, professionally and managerially 6.53 The role of the AE(D) should be fully
responsible (and accountable to the independent of the healthcare facilities’
Decontamination Lead) for the engineering structure for maintenance, testing and
aspects of decontamination (for example, management of the decontamination
decontamination equipment and the equipment.
environment).
6.54 The AE(D) is defined as a person
designated by Management to provide
User
independent auditing and technical advice on
6.49 The User is defined as the person decontamination procedures, washer-
designated by Management to be responsible disinfectors, sterilizers and sterilization and to
for the management of the process. The User review and witness documentation on
is also responsible for the Operators. validation.

6.50 In the acute sector, the User could be a 6.55 The AE(D) is required to liaise closely with
sterile services manager. other professionals in various disciplines and,
consequently, the appointment should be made
6.51 The principal responsibilities of the User known in writing to all interested parties.
are as follows:
6.56 The AE(D) should assist healthcare
• to certify that the decontamination
organisations in the appointments and
equipment is fit for use;
interviews of the AP(D)s and their consequent
• to hold all documentation relating to the annual assessments.
decontamination equipment, including
• The AE(D) should have a reporting route
the names of other key personnel;
to the Decontamination Lead and should

28
6 Management of surgical instruments

provide professional and technical advice The Institute of Healthcare Engineering and
to the AP(D)s, CP(D)s, Users and other Estate Management (IHEEM) supports and
key personnel involved in the control of operates the DTP (Decontamination
decontamination processes in all Technology Platform) which is made up of
healthcare facilities. IHEEM-registered AE(D)S (see link in the
References section).
Responsibilities
6.57 The principal responsibilities of the AE(D)
Authorised Person (Decontamination)
are as follows:
(AP(D))
• to provide to Management and others, 6.59 See ‘Responsibilities’ in HTM 01-01 Part
general and impartial advice on all B.
matters concerned with decontamination;
• to advise Management and others on Competent Person (Decontamination)
programmes of validation and testing; (CP(D))
• to audit reports on validation, revalidation 6.60 See ‘Responsibilities’ in HTM 01-01 Part
and yearly tests submitted by the AP(D); B.

• to advise Management and others on

Director of Infection Prevention and Control
programmes of periodic tests and
(DIPC)
periodic maintenance;
6.61 The DIPC in England is defined as the
• to advise Management and others on person responsible for the infection control
operational procedures for routine aspects of decontamination. The designated
production; person is accountable directly to the Chief
• to advise Management on the Executive and to the Board. If the person has a
appointment of the AP(D); degree or equivalent qualification in
microbiology, he/she may also fulfill the role of
• to provide technical advice on purchasing the Microbiologist (Decontamination).
and selection of decontamination
equipment for the users;
Infection Control Doctor
• to provide technical advice on the 6.62 The Infection Control Doctor is defined as
relevant guidance on decontamination a person designated by Management to be
equipment and procedures. responsible for advising the User on all infection
control aspects.
6.58 Each appointed AE(D) is independent in
the advice and roles of the decontamination
procedures and responsibilities for the effective Microbiologist (Decontamination)
management of the guidance and safety as 6.63 The Microbiologist (Decontamination) is
recommended by the DH and regional designated by Management to be responsible
administrations of Scotland, Wales and for advising the User and that Management on
Northern Ireland. microbiological and infection prevention
aspects of the decontamination of reusable
surgical instruments.

6.64 The Microbiologist (Decontamination)

should have a relevant degree or equivalent
qualification (for example, microbiology or

29
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

medicine) together with relevant experience. In Contractor

some organisations, the Microbiologist
(Decontamination) and Infection Control Doctor 6.68 See ‘Responsibilities’ in HTM 01-01
may be the same person. Part B.

Operator Purchaser

6.65 The Operator is defined as any person 6.69 See ‘Responsibilities’ in HTM 01-01
with the authority to operate decontamination Part B.
equipment, including the noting of instrument
readings and simple housekeeping duties. Competent Person (Pressure Systems)
6.70 The Competent Person as defined in the
6.66 Operators should have their tasks defined
Pressure Systems Safety Regulations 2000 is
in their job description. Operators should also
not the same person as the Competent Person
have documented training records to
(Decontamination) defined in this HTM. The
demonstrate that they are competent at
former is a chartered engineer responsible for
undertaking their assigned tasks.
drawing up a written scheme of examination for
the system. The latter is the person who carries
Manufacturer out maintenance, validation and periodic testing
6.67 See ‘Responsibilities’ in HTM 01-01 of washer-disinfectors and sterilizers.
Part B.
6.71 Most insurance companies maintain a
technical division able to advise on appointing a
CP(PS). The AE(D) should also be able to
provide advice.

30
Appendix A: Standards relevant to decontamination

Appendix A: Standards relevant to

decontamination

Standards relevant to BS EN 14180:2003+A2. Sterilizers for medical

purposes. Low temperature steam and
decontamination processes and formaldehyde sterilizers. Requirements and
equipment testing.
BS EN ISO 11737-1. Sterilization of medical BS EN ISO 15883-1. Washer-disinfectors.
devices. Microbiological methods. General requirements, terms and definitions
Determination of a population of and tests.
microorganisms on products.
BS EN ISO 15883-2. Washer-disinfectors.
BS EN ISO 11737-2. Sterilization of medical Requirements and tests for washer-disinfectors
devices. Microbiological methods. Tests of employing thermal disinfection for surgical
sterility performed in the definition, validation instruments, anaesthetic equipment, bowls,
and maintenance of a sterilization process. dishes, receivers, utensils, glassware, etc.
BS EN ISO 14937. Sterilization of health care BS EN ISO 13485. Medical devices. Quality
products. General requirements for management systems. Requirements for
characterization of a sterilizing agent and the regulatory purposes.
development, validation and routine control of a
sterilization process for medical devices.
Standards relevant to
BS EN ISO 17665-1. Sterilization of health care
products. Moist heat. Requirements for the
decontamination management
development, validation and routine control of a BS EN ISO 13485. Medical devices. Quality
sterilization process for medical devices. managements systems. Requirements for
(This includes porous load and fluid sterilizers regulatory purposes.
(except where used for medicinal products),
and sterilizers for unwrapped instruments and
utensils.) Standards relevant to safety
requirements for decontamination
BS EN 285. Sterilization. Steam sterilizers.
Large sterilizers.
equipment
BS EN 61010-2-040. Safety requirements for
BS EN 13060. Small steam sterilizers. electrical equipment for measurement, control
and laboratory use. Particular requirements for
BS EN 1422. Sterilizers for medical purposes. sterilizers and washer- disinfectors used to treat
Ethylene oxide sterilizers. Requirements and medical materials.
test methods.

31
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

BS EN ISO 13849-2. Safety machinery. Safety- designated ‘STERILE’. Requirements for

related parts of control systems. Validation. aseptically processed medical devices.

BS EN 1041:2008+A1. Information supplied by

Standards relevant to medical the manufacturer of medical devices.
devices
BS EN ISO 14971. Application of risk
BS EN 556-1. Sterilization of medical devices. management to medical devices.
Requirements for medical devices to be
designated ‘STERILE’. Requirements for BS EN ISO 17664. Sterilization of medical
terminally sterilized medical devices. devices. Information to be provided by the
manufacturer for the processing of resterilizable
BS EN 556-2. Sterilization of medical devices. medical devices.
Requirements for medical devices to be

32
Appendix B: Example sampling strategy

Appendix B: Example sampling strategy

This Appendix contains guidance on how of the cleaning process setting a benchmark
routine measurement of residual protein on derived from earlier observations with the
surgical instruments can be implemented. New expectation of sequential reductions in that
technologies that quantify residual proteins on benchmark being possible as the cleaning
washed instruments are being developed, but process is refined. It may also demonstrate
there is no pre-existing experience of assessing inter-instrument variation, much of which is
and analysing protein levels on reprocessed likely to arise due to inherent instrument
surgical instruments. This suggested approach features such as box joints.
to sampling may be adapted in future guidance
as the knowledge base increases. It is likely that measurements made across
several instrument types follow a positively
The use of these technologies opens up the skewed distribution (that is, a small number of
possibility to assess the impact of changes to high measurements when compared with the
decontamination parameters (for example, majority). This could best be seen in a
changes in detergents, wash times, wash histogram of results.
temperatures). However, this guidance
considers only the monitoring of the totality of
those parameters associated with protein Determining the baseline
removal (this may include the time between The first step is for an SSD to measure
instrument use and cleaning as well as the reprocessed surgical instruments representing
cleaning parameters themselves). This can be the full range of their workload to provide the
considered as general guidance in the basis upon which a monitoring system can be
establishment of an internal quality assurance developed. The measurement scale can be
scheme (IQAS). considered as continuous. If a single
measurement is to be made at each time point,
The proportion of surgical instruments where an individuals and moving range (I-MR) chart
residual protein exceeds the 5 µg threshold is can be used. If it is considered more
expected to be very low. The use of these appropriate to group instruments into batches
technologies to attempt to either identify types (for example, five instruments per week), it may
of instrument or estimate the percentage of be appropriate to use an Xbar and range
reprocessed instruments within an SSD (Xbar-R) chart (Xbar = plotting the average of
exceeding this threshold is extremely batches; range = plotting the maximum minus
challenging. the minimum of each batch). Either method
constructs two charts: one monitoring the
The ability to make definitive statements would process average, the other monitoring process
require an extremely large number of variation.
measurements to be made, which would be
prohibitive in terms of disruption to the As it is likely that the distribution of the residual
availability of instrument sets. protein across all instrument types is positively
skewed, a logarithmic transformation may
However, it is possible to design an IQAS with provide a more suitable measurement for
the aim of monitoring, over time, the efficiency monitoring. Estimates of the process average

33
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

measurement and the variation between which parameters of the process can be
measurements are required to construct estimated, although these should be
statistical process control charts used for periodically re-estimated from a set of
monitoring future measurements. A total of 20 measurements made when the process is
measurements should suffice initially from considered to be “in control”.

Example
Consider that each working day a single reprocessed instrument is measured, and the
measurements in µg are entered into an Excel worksheet. This data will be used to demonstrate
how to set up both an I-MR and an Xbar-R chart.

I-MR Chart In this example the average is 1.56 and the

standard deviation is 1.95. If, as in this example,
Once the first 20 measurements have been
the standard deviation is larger than three-
obtained, these are inspected to assess their
quarters of the average, this indicates that the
distribution. The simplest approach is to
distribution of the measurements is not
calculate the average and standard deviation,
symmetric. It is therefore advisable to use the
which in Excel can be achieved using the
logarithms of the measurement rather than the
AVERAGE() and STDEV() functions, respectively,
measurements themselves. Excel has a number
putting the cell range into the parentheses. For
of logarithmic functions depending on which
example, the average of the measurements in
base is chosen. In this example, logarithms to
cells D2 to D21 (inclusive) is calculated using
the base 10 are used, but it is also acceptable
the formula =AVERAGE(D2:D21).
to use natural logarithms.

34
Appendix B: Example sampling strategy

The Excel function for base 10 logarithms is enter the function =LOG10(D2) to put the
LOG10(), where the parentheses contain the logarithm to the base 10 of D2 into cell F2.
cell to be transformed. For example, in cell F2

35
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

This formula can be copied down cells F3 to F21 by clicking and holding the bottom right corner
of the cell and dragging the cursor to cell F21.

The absolute value of the difference between subsequent measurements now has to be
calculated – that is, the magnitude of the measurement in row k minus the measurement in
row k – 1. For example, to enter the difference between cells F3 and F2 in cell G3, enter into cell
G3 the formula =ABS(F3–F2) and press the return key.

36
Appendix B: Example sampling strategy

This formula can be copied as described previously to obtain a column with 19 differences.

The centre line and control limits for the I-MR charts are estimated from the 20 measurements and
19 absolute differences. For the individuals chart the centre line is the average (x or Xbar) of the 20
log10 (measurements) in column F.

The lower and upper control limits (LCL, UCL) The quantity of MR/1.128 provides an estimate
are calculated using the formula: of the standard deviation. It is conventional to
use 3 for the value of k, this providing limits of
plus and minus three standard deviations. If k is
MR
x ±k set to 3 then the above formula simplifies to
1.128 x ± 2.66 × MR. For the example, the formula
=J4–2.66*J9 and =J4+2.66*J9 are used for the
where MR (also written as MRbar) is the LCL and UCL, respectively.
average of the 19 absolute differences.

37
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

For the MR chart, the centre line of the chart is MR, the average absolute differences.

A similar approach to that above – subtracting and adding three standard deviations – is used to
obtain the control limits, but these simplify to a multiple of MR. These limits are obtained by the
formulae LCL = 0 and UCL = 3.267 × MR. The limits obtained are then used in tables or charts to
monitor future measurements.

In the example above, only one measurement If is important to realise that even if all
made on 11/05/2016 of 18.63 µg falls above the measurements fall within the LCL and the UCL,
UCL. Measurements that fall outside of the this does not necessarily mean that the
control limits are an indication that the process process is in control. What is important is
is no longer in control. This may warrant an whether there appears to be any systematic
investigation to detect and eliminate any behaviour in sequential measurements. For
underlying causes. However, it may be example, if there were ten successive
expected to observe these occasionally due measurements all above the centre line, then
purely to chance. this might indicate that a systematic change to
the process has occurred, since we would
expect half of these measurements to fall either

38
Appendix B: Example sampling strategy

side of the centre line when the process is in below the centre line, six consecutive
control. To aid interpretation of statistical measurements where there is a monotonic
process control charts, a series of situations trend (all increasing or decreasing), or 14
that may indicate an “out of control” process consecutive measurements where there is an
have been suggested. Thus, situations such as alternating pattern would all suggest an “out of
eight consecutive measurements above or control” process.

39
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Xbar-R chart of measurements are calculated. To construct

the Xbar-R chart, the average of both the group
These charts are best used when
average and range from a small number of
measurements naturally fall into groups, for
groups is required. A minimum of 20
example per week, where the same number of
measurements is likely to be sufficient to set an
reprocessed instruments are measured. These
initial benchmark, that is, four weekly groups
groups would normally consist of between two
each of five measurements. The group
and ten instruments. In each group the average
averages are calculated using the AVERAGE()
and the range (maximum–minimum) of the set
function:

The range within each group is obtained using the MAX() and MIN() functions. For example,
=MAX(F2:F6) – MIN(F2:F6) will calculate the range in the first batch.

These are then used to calculate the centre lines, LCLs, and UCLs of the Xbar and R charts.

For the Xbar chart, the average of the group averages (x) provides the centre line. The LCL and
UCL are obtained from the formula:

x ± A2R,

where A2 is a multiplier depended only on the number of measurements in each group (n), and R
is the average of the group ranges. For group sizes (n) of 5, A2 is 0.577.

40
Appendix B: Example sampling strategy

For the R chart the average of the group ranges (R) provides the centre line. The LCL and UCL are
obtained from the formulae D3R and D4R, where both D3 and D4 are multipliers depended only
upon the number of measurements in each group (n). For group sizes (n) of 5, D3 is 0, and D4 is
2.115.

The values of these multipliers are tabulated below for group sizes between 2 and 10, inclusive.

Group Multiplier
size

n A2 D3 D4

2 1.880 0 3.267

3 1.023 0 2.575

4 0.729 0 2.282

5 0.577 0 2.115

6 0.483 0 2.004

7 0.419 0.076 1.924

8 0.373 0.136 1.864

9 0.337 0.184 1.816

10 0.308 0.223 1.777

41
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

For the next 16 weeks of groups of five measurements, the data required for the Xbar and R
charts are calculated and charts produced.

42
Appendix B: Example sampling strategy

Ongoing monitoring The instruments stated above should reflect

those used to develop the benchmark. This
Monitoring reprocessing of instruments by the process is thought to provide the best balance
use of statistical control charts provides between generating informative data and the
assurance that the process is working as inevitable disruption such testing will cause.
anticipated, and the residual protein on
instruments is within the range expected. Further technical details on statistical process
control charts are available in Chapter 6
A chart for each wash chamber/WD should be “Monitor” of the NIST/SEMATECH e-Handbook
set up. The number and types of instruments of Statistical Methods (see References).
should be tested as follows:

50 instruments per wash chamber/WD, Note:

at least every three months, chosen
from difficult-to-clean instruments (for This test is not expected to be carried out
example, box joints, serrations, hinges, as part of the periodic quarterly tests, but
graters and reamers and complex will be performed as an ongoing intermittent
retractors) where used. Other difficult- series throughout a three-month cycle.
to-clean instruments should be
identified and included in this testing.

43
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

References

Health Act Code of Practice. BS EN ISO 13485.

NICE IPG 196 (2006). Executive Letter EL(98)5.

Health Technical Memorandum 01-01 – Decontamination Services Agreement.

Management and decontamination of surgical
instruments (medical devices) used in acute In-vitro Diagnostic Devices Directive.
care. Part B – Common elements.
Kirby, E., Dickinson, J., Vassey, M., Dennis, M.,
Health Technical Memorandum 01-01 – Cornwall, M., Mcleod N. et al. (2012). Bioassay
Management and decontamination of surgical studies support the potential for iatrogenic
instruments (medical devices) used in acute transmission of Variant Creutzfeldt Jakob
care. Part C – Steam sterilization. Disease through dental procedures. PLoS ONE,
7(11). http://dx.doi.org/10.1371/journal.
Health Technical Memorandum 01-01 – pone.0049850.
Management and decontamination of surgical
instruments (medical devices) used in acute Active Implantable Medical Devices Directive.
care. Part D – Washer-disinfectors.
Health and Social Care Act 2008 (Regulated
Health Technical Memorandum 01-01 – Activities) Regulations 2010.
Management and decontamination of surgical
instruments (medical devices) used in acute European Union website.
care. Part E – Alternatives to steam for the
sterilization of reusable medical devices. MHRA.

The Health and Social Care Act 2008: Code of CMO letter 2007/2.
Practice on the prevention and control of
CMO letter 2008/2.
infections and related guidance.
Hilton and Ironside (2003).
Medical Devices Directive.
Guidance from the ACDP-TSE RM Subgroup.
Revision to the Medical Devices Directive.
CJD Incidents Panel.
CQC Guidance about compliance.
ACDP-TSE RM Annex J.
GS1 coding.
ACDP-TSE RM: ‘TSE Agents. Safe Working and
NHS Operating Framework 2012/13.
the Prevention of Infection – Part 4’.
Medical Devices Regulations (MDR) 2002.

44
References

ACDP-TSE RM guidance on infection control of

prion diseases (Part 4).

ACDP-TSE RM guidance Annex L.

IHEEM AE(D) register.

Institute of Decontamination Sciences (IDSc).

Institute of Healthcare Engineering and Estate

Management (IHEEM).

ESAC-Pr report.

MHRA’s ‘Managing medical devices: guidance

for healthcare and social services
organisations’

MHRA ‘Medical devices: conformity

assessment and the CE mark’.

NIST/SEMATECH e-Handbook of Statistical

Methods.

45
HTM 01-01: Management and decontamination of surgical instruments: Part A – Management and provision

Bibliography of research articles

Hervé, R.C. and Keevil, C.W. (2013) Current from theatre to central sterile service
limitations about the cleaning of luminal departments. J. Hosp Infect. 65(1). 72–77.
endoscopes. J. Hosp. Infect. 83(1). 22–29.
Secker, T.J., Hervé, R.C. and Keevil, C.W. (2011)
Hervé, R.C., Collin, R., Pinchin, H.E., Secker, Adsorption of prion and tissue proteins to
T.J. and Keevil, C.W. (2009) A rapid dual surgical stainless steel surfaces and the
staining procedure for the quantitative efficacy of decontamination following dry
discrimination of prion amyloid from and wet storage conditions. J. Hosp. Infect.
tissues reveals how interactions between 78(4). 251–255.
amyloid and lipids in tissue homogenates
may hinder the detection of prions. Secker, T.J., Pinchin, H.E., Hervé, R.C. and
J. Microbiol Methods. 77(1). 90–97. Keevil, C.W. (2015) Efficacy of humidity
retention bags for the reduced adsorption
Hervé, R.C., Secker, T.J. and Keevil, C.W. (2010) and improved cleaning of tissue proteins
Current risk of iatrogenic Creutzfeld- including prion-associated amyloid to
Jakob disease in the UK: efficacy of surgical stainless steel surfaces. Biofouling.
available cleaning chemistries and 31(6). 535–541.
reusability of neurosurgical instruments.
J. Hosp Infect. 75(4). 309–313.

Keevil, C.W. (2003) Rapid detection of

biofilms and adherent pathogens using
scanning confocal laser microscopy and
episcopic differential interference
contrast microscopy. Water Sci Technol.
47(5). 105–116.

Lipscomb, I.P., Hervé, R.C., Harris, K., Pinchin,

H.E., Collin, R. and Keevil, C.W. (2007)
Amyloid-specific fluorophores for the
rapid, sensitive in situ detection of prion
contamination on surgical instruments.
Journal of General Virology. 88(9). 2619–2626.

Lipscomb I.P., Pinchin, H., Collin, R. and Keevil

C.W. (2007) Effect of drying time, ambient
temperature and pre-soaks on prion-
infected tissue contamination levels on
surgical stainless steel: concerns over
prolonged transportation of instruments

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HTM 01 01 PartA

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HTM 01 01 PartA

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Health Technical Memorandum

01-01: Management and

Health Technical Memorandum

Introduction HTM 01-01 forms a suite of evidence-based

Professor Dame Sally Davies

The ACDP-TSE Subgroup’s guidance What SSDs can do to ensure

Implementation of guidance List of major changes to Part A

Andrew Bent Medicines & Healthcare products Regulatory Agency

ACDP-TSE [Subgroup]: Advisory Committee on FITC: fluorescein isothiocyanate

ACDST: Advisory Committee on MDD: Medical Devices Directive

BCH: Birmingham Children’s Hospital NDS: National Decontamination Survey

CMO: Chief Medical Officer OPA/NAC:

EFSCAN: epifluorescent surface scanner

EN: European norm

Figure 1 The reusable surgical instrument cycle

ACQUISITION The reusable surgical

Committee on Dangerous Pathogens – the formulation of a locally developed, risk-

1.10 HTM 01-01 Part A supersedes all previous

Structure of HTM 01-01

2 Decontamination policy for reusable surgical

2.19 This applies to decontamination facilities • the surgical instrument manager;

Figure 2 Drivers for quality improvements and desired outcomes

Staff safety Medical Devices

Implementation of HTM 01-01 leakage when combined with set colour

The ACDP-TSE Subgroup’s guidance What SSDs can do to ensure

• daily testing using process challenge

Methods for detecting residual protein

3.9 Regulators may use the recorded risk-

Implication for contractual

English Legislation (this is not an exclusive list)

British, European and International Standards Healthcare Standards

•D H Guidance (HTMs and Health Building Notes

decontamination services and which “place provides a standardised approach to

Regulation and audit of decontamination services

Decontamination carried out off-site Decontamination carried out on-site

Regulation by MHRA Regulation by CQC

Audit by a notified body Local self-audits by provider

4.14 BS EN ISO 13485 specifies requirements 4.16 A notified body is a certification

• non-conformances picked up in the The Health and Social Care Act

• Using a decontamination service that is • it complies with guidance establishing

• Using CE-marked single-use medical • decontamination of reusable medical

5 Human prion diseases (including variant CJD

vCJD is distinguishable from non-vCJD in a number of ways:

Guidance from the Advisory Committee on Dangerous Pathogens Transmissible Spongiform

What is the relevance of decontamination to human prion diseases?

inactivate by conventional decontamination

Lymphoid tissues are considered medium 5.9 Part 4 also describes:

quarantine if indicated) or use of instruments Prion-specific decontamination

6 Management of surgical instruments

Introduction Keeping instruments moist between

6.4 Other management choices covered in this Separation of instruments used on

Figure 5 Instrument stock identification for high-risk tissue surgery

Born after Use pre-1997 Return

1 This reflects guidance by the Society of British Neurological

adherence to scheduled instrument Decontamination of surgical

6.29 There should be measures in place to

Staff roles and responsibilities 6.30 Staff undertaking decontamination and

• Executive Manager (for example, chief responsibility for decontamination, either at

• Surgical Instruments Manager 6.39 The Decontamination Lead is

• Contractor; 6.41 The Decontamination Lead may delegate

Surgical Instrument Manager/coordinator • oversee the audit process for instrument

audited on a regular basis, and all • to ensure that decontamination

Senior Operational Manager Authorising Engineer (Decontamination)

• to advise Management and others on

6.64 The Microbiologist (Decontamination)

medicine) together with relevant experience. In Contractor

Appendix A: Standards relevant to

Standards relevant to BS EN 14180:2003+A2. Sterilizers for medical

BS EN ISO 13849-2. Safety machinery. Safety- designated ‘STERILE’. Requirements for

BS EN 1041:2008+A1. Information supplied by

Appendix B: Example sampling strategy

I-MR Chart In this example the average is 1.56 and the

Xbar-R chart of measurements are calculated. To construct

7 0.419 0.076 1.924

8 0.373 0.136 1.864

9 0.337 0.184 1.816

2 Decontamination policy for reusable surgical

•D H Guidance (HTMs and Health Building Notes

5 Human prion diseases (including variant CJD

1 This reflects guidance by the Society of British Neurological